D-0736-2023 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2023
- Initiation Date
- April 28, 2023
- Termination Date
- June 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8252 bags
Product Description
vancomycin added to 0.9% sodium chloride, 1.75 g/500 mL* (3.5 mg/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-7060-1.
Reason for Recall
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Distribution Pattern
Nationwide in the USA.
Code Information
Lot # 37-884152, 37-884158, Exp 05/03/2023; 37-885300, 37-885302, 37-885307, Exp 05/08/2023; 37-887418, 37-887431, 37-887432, Exp 05/16/2023; 37-888850, 37-888852, 37-888853, Exp 05/22/2023; 37-889188, Exp 05/23/2023; 37-890892, 37-890894, 37-890897, Exp 05/30/2023; 37-891232, Exp 05/31/2023; 37-892014, 37-892017, Exp 06/05/2023; 37-894411, 37-894412, 37-894414, Exp 06/13/2023; 37-894659, Exp 06/14/2023; 37-896078, 37-896089, 37-896097, Exp 06/20/2023; 37-897369, Exp 06/26/2023